Who is eligible for clinical trial NCT07011706?

Participants must meet protocol criteria for Atopic Dermatitis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07011706 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-24

ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (NCT07011706)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Aclaris Therapeutics, Inc.

🩺 Plain-English Summary (8th-Grade Level)

This study evaluates ATI-045 versus placebo in patients with Moderate-to-Severe Atopic Dermatitis.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (15 items).

Location: Aclaris Clinical Site — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Diagnosis of chronic atopic dermatitis that has been present for ≥ 6 months before the screening visit and with no significant AD flares during the past 4 weeks before screening
Have active moderate to severe AD at screening and baseline visits
EASI score ≥ 16 and ≥10% BSA at the screening and baseline visits
History of inadequate response to treatment for AD with topical medications; or determination that topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks)
Patient applied a stable dose of non-medicated topical moisturizer (ideally once or twice daily) for ≥ 7 days prior to the baseline visit and agrees to continue use during study

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Treatment with any of the following:
Intravenous immunoglobulin within 12 weeks prior to the baseline visit (W0D1)
Systemic antibiotics within 2 weeks prior to the baseline visit (W0D1)
Topical antibiotics within 1 week prior the baseline visit (W0D1)
Topical medicated treatment that could affect atopic dermatitis should be prohibited for at least 2 weeks prior to baseline visit. Example: topical corticosteroids, crisaborole, calcineurin inhibitors, ruxolitinib, roflumilast, tars, antimicrobials, medical devices, and bleach baths.
Topical products containing urea within 1 week prior to baseline visit (W0D1)
Doxepin, hydroxyzine, or diphenhydramine within 1 week prior to the baseline visit (W0D1)
Patient has used systemic treatments (other than biologics) that could affect AD less than 4 weeks or 5 half-lives (whichever is longer) prior to the baseline visit (W0D1), including, but not limited to, retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids, baricitinib, upadacitinib, and abrocitinib.
Biologics for AD treatments (such as dupilumab, tralokinumab, lebrikizumab, investigational biologics) within 5 half- lives or 12 weeks, whichever is longer prior to the baseline visit (W0D1)
An investigational drug (non-biologic) within 4 weeks or within 5 half-lives (if known), whichever is longer prior to the baseline visit (W0D1)
Phototherapy and photochemotherapy for AD within 4 weeks prior to the baseline visit (W0D1)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗

ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (NCT07011706)

🩺 Plain-English Summary (8th-Grade Level)

📋 "Do I Qualify?" — 1-Minute Self Screener

Usually NOT eligible if any of the following apply:

📍 All Participating Trial Locations (60 Sites)

💰 Cost, Insurance & Patient Rights